Applications Cleanroom Labels

Cleanroom Labels

Precise Identification and Traceability in Controlled Environments

Cleanroom labels are used in contaminant-controlled environments to identify, describe, and track information on products and packages. Cleanrooms are controlled environments with low levels of airborne particles and contaminants, typically used in biotech, pharmaceuticals, medical devices, aerospace, and healthcare industries. In such controlled cleanroom environments, precise identification and traceability are paramount. Our cleanroom labels offer exceptional performance, ensuring reliable identification and accurate tracking while maintaining the highest standards of cleanliness. With their low particle generation, minimal outgassing, and compatibility with cleanroom surfaces, our cleanroom labels support your cleanroom protocols and enhance operational efficiency. Explore our comprehensive range of cleanroom labels and discover how they can elevate your cleanroom processes.

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Best Practices Guide

Product Resources

labels made for use in cleanrooms

Why Choose Our Cleanroom Labels

Low-Particle Generation

Our cleanroom comprises materials that minimize particle generation. 

They mitigate the shedding of particles, fibers, or contaminants that could compromise the cleanliness of the environment. We have low-linting materials, including polypropylene, polyester, polycarbonate, and polyimide.

Cleanliness Classification

Our cleanroom labels are ISO 5 (class 100) cleanroom processed per international standards, such as ISO 14644-1. The cleanliness level indicates the maximum allowable concentration and size of particles that the label can generate. Please refer to the table below for the classification particle allowances. 

Compatibility with Cleanroom Surfaces 

Our labels adhere effectively to various cleanroom surfaces, including plastics, metals, glass, or other commonly used materials. We have options for strong adhesion to prevent label detachment or peeling, even in the presence of cleanroom wipes or cleaning protocols. Additionally, for applications that require a clean surface post-label removable, we offer several labels for clean removability.   

Print Legibility

Each cleanroom label's surface is smooth, allowing for clear and crisp printing of essential information, such as item identification, lot numbers, barcodes, or safety warnings. Legible printing is crucial for accurate identification and tracking within the cleanroom environment.

Minimal Outgassing

Cleanroom labels use adhesives with low outgassing properties. Outgassing refers to releasing volatile organic compounds (VOCs) from the adhesive over time. Cleanroom labels employ adhesives tested and selected to minimize or eliminate VOC emissions, preventing contamination in the cleanroom environment.

Chemical Resistance 

Our cleanroom labels resist various cleaning agents, disinfectants, and chemicals used in cleanroom maintenance. When exposed to these substances, they will not degrade, fade, or lose adhesion. 

Cleanroom Label Options

Direct Thermal Cleanroom Labels

Designed for use in direct thermal printers that directly prints text and images via applying heat to a label embedded with thermochromic ink.

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Thermal Transfer Cleanroom Labels

Made for thermal transfer printers that print text and images by transferring ink from heat sensitive ribbons to the label surface.

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Custom Made Cleanroom Labels

Our cleanroom labels are fully customizable to satisfy a wide range of technical requirements. We are here to understand your needs end-to-end to develop a complete label construction unique to your application.

Form Factor

Die cut and tailor your labels to fit practically any dimension or containers, products, and packaging

Construction Type

Available in rolls or sheets, piggyback, and label set constructions

Topcoat Finish

Choose from a variety of matte, gloss, and semi-gloss topcoat selections

Printing Options

Compatible with thermal transfer, direct thermal, inkjet, and standard laser printers

Adhesive Grade

Pick from permanent, semi-removable, and removable adhesives

Sterile Indicating

Utilize chemical indicators that fit your sterilization processing method

Printing Capability

Labels can be fully printed, partially printed, blank, or hand writeable

Material Selection

Select from multiple forms of premium facestocks, plastic cores, and liners

Surface Resistance

Can provide material that exhibit chemical, moisture, UV, and temperature resistance

Find The Right Cleanroom Labels

In order to find cleanroom labels that perform and properly satisfy your quality standards, it is important to partner with a label expert familiar with a wide array of controlled environment applications. Our team has extensive experience working with companies involved with advanced research and manufacturing. We can work in tandem with your technical team to design, prototype, and manufacture cleanroom labels that are engineered for your application. Our aim is to make this quick and easy for you. 

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Label features
  • Particle-flow controlled - Cleaned, slit, rewound, and packaged in a Class 100 cleanroom
  • Odor controlled - made with low outgassing adhesives
  • Waterproof - label will not lift or tear apart when submerged under water
  • Smudge resistant - will remain legible when wet or when written with permanent marker
  • Tear free - removes from high and low surface energy surfaces easily without ripping apart
  • Residue free - labels remove cleanly from surfaces
  • Regulation Compliance - Can be configured to fit any GHS, OSHA, GMP, or FDA labeling requirements and standards
Applications of cleanroom labels
  • Pharmaceutical and Biotechnology: Cleanroom labels have extensive use in pharmaceutical and biotechnology industries for labeling sterile products, pharmaceutical packaging, vials, syringes, and other medical supplies. These labels ensure accurate identification and traceability while maintaining the cleanroom environment.

  • Electronics Manufacturing: Cleanroom labels find application in electronics manufacturing facilities for labeling electronic components, circuit boards, sensitive equipment, and cleanroom tools. These labels help prevent contamination and provide accurate identification during assembly and production processes.

  • Semiconductor Industry: Cleanroom labels are crucial in the semiconductor industry for labeling silicon wafers, microchips, and other electronic components manufactured in cleanroom environments. These labels assist in the accurate tracking and identification of sensitive materials.

  • Medical Device Manufacturing: Cleanroom labels are utilized in medical device manufacturing facilities for labeling cleanroom tools, components, and finished medical devices. These labels ensure proper identification and traceability in controlled environments.

  • Aerospace and Defense: Cleanroom labels find application in aerospace and defense industries for labeling cleanroom tools, components, and equipment used in the manufacturing and assembly of aerospace products. These labels help prevent contamination and ensure accurate identification.

  • Optics and Precision Engineering: Cleanroom labels are used in optics and precision engineering industries for labeling cleanroom tools, optical components, lenses, and other sensitive equipment. These labels maintain cleanliness and prevent damage or contamination.

  • Research and Development Laboratories: In research and development laboratories for labeling cleanroom instruments, equipment, and samples. These labels assist in accurate identification and traceability within controlled environments.

  • Food Processing and Packaging: Cleanroom labels find application in food processing and packaging facilities where cleanliness and prevention of contamination are critical. These labels identify cleanroom tools, packaging materials, and sensitive equipment used in food production processes.

  • Automotive Manufacturing: Cleanroom labels are utilized in automotive manufacturing facilities for labeling cleanroom tools, precision components, and assemblies. These labels help maintain cleanliness and prevent contamination during the manufacturing process.

  • Cleanroom Facilities and Laboratories: Cleanroom labels are essential for labeling doors, equipment, storage areas, and workstations within cleanroom facilities and laboratories. These labels help maintain organization, prevent cross-contamination, and ensure adherence to cleanroom protocols.

Application spotlight
CleanMark - Cleanroom Label Application Spotlight
Our customer’s previous method of identifying equipment and plates pre/post incubation cycles via adhesive label application to a 3.5" index card followed by placing the index card/label combo inside a plastic slip was unsatisfactory. The manufacturing team required a solution that:
  1. Allows them to bypass their current labeling process
  2. Exhibits resistance to isopropyl alcohol (IPA)
  3. Is hand-writable with a ball-point pen or fine tip permanent marker to maximize writing space
CleanMark systematically addressed their requirements by first crafting a text and color templated pressure-sensitive adhesive (PSA) label, allowing for direct surface contact and time saved on writing static items. However, the latter two requirements presented a unique challenge to work synergistically together. The fundamental ability to write on a surface is dependent on the surface’s topography and interface energy, ink penetration, and wettability. Surfaces that are typically very smooth with ≤ 40 dyne/cm surface energy are often incompatible with high surface tension aqueous inks as the pen does not have enough capillary action to draw out ink. To achieve IPA resistance, a smooth lipophobic top is standard, but is not viable in this case. We constructed a tag material with UV matte image coat for protection instead. This UV matte coat not only protects the preprinted templates from IPA and other organic solvents, but the rough surface allows for handwriting with solvent-based fine tip markers. 
Design considerations
  1. What type of printing material do you need for your application?

    • Synthetic (BOPP, PE, PET, etc.)

  2. Will your label need to be processed as a roll or a sheet?

  3. Do your labels need to be clean or clean and sterile?

    • Clean = free of particulate matter

    • Sterile = free of microbial contamination

  4. Does your label require resistance from moisture, high heat, organic solvents, UV radiation or extreme cold?

  5. Is proof of process sterilization required or desired?

    • What type of sterilization are you performing?

    • Is box level proof sufficient evidence or is itemized level proof required?

    • How or where should such evidence be present on the label for clear viewing?

  6. What information is needed on a label?

    • Who is going to read the label?

    • Does it require tracking and/or tracing capabilities?

    • Are there specific regulatory requirements that need to be present on the label?

    • Do you need to maximize information content on the label?

    • What colors are needed and in what arrangement?

  7. What are the dimensions and size of the container being used?

    • Is this going on a box or smaller vial?

    • Does the label need to lie flat with it wrapped around?

    • Does the label required non-standard die-cuts?

    • Is the surface flat or curved?

Frequently asked questions

1. What is the difference between cleanroom labels and cleanroom tags? 

Cleanroom tags are adhesive-free labels that are attached to the item of choice by hanging or tying.

2. What options are available for label adhesives?

We have multiple adhesive options ranging from high tack and peel strength permanent adhesion for sticky labels to easy-to-remove labels for          those that wish to reuse their product post labeling.

3. What label would you recommend for easy peel off so that I do not have to spend extra time washing off adhesive residue?

Our ultra removable label is suitable for customers who want to avoid additional washing cycles due residue left by the label. These labels do not leave behind the phantom ring often seen post peeling.

4. How do you support GHS (Global Harmonized System), OSHA (Occupational Safety and Health Administration), FDA (Food and Drug Administration) and GMP (Good Manufacturing Practices) label printing requirements for cleanrooms?

We will work with you to understand the intricate details of your specific labeling requirements to ensure that you are in full compliance with any regulating body cleanroom standards.

5. How do you support requirements for cleanroom label product identification, asset tracking, tracing back chain of custody (provenance), and general label inventory?

We can support you in a number of ways. We can customize any design you need to fit to any packaging. We can print out barcodes, UPC code, and/or QR codes. This can be combined with any templates you need to make your tracking and identification needs easier to manage. 

6. What type of printers are your cleanroom labels compatible with or commonly used on?

Labels are made for use with a wide variety of thermal printers (direct or thermal transfer) and inkjet printers including DYMO 4XL, the Zebra GK420, Rollo Thermal Label Printer, Epson Colorworks, etc.

7. What type of products and items can you produce labels to fit to?

  • Cleanroom bags (HDPE, LDPE, ESD, Nylon, etc.)
  • Pipes and tubing

  • Circuit boards 

  • Cables and wires 

  • Corrugated cardboard boxes 

  • Glassware (scintillation vials, beakers, gradulated cylinders, flask, etc.)

  • Plasticware

8. What are the cleanroom classification standards?                       

CleanMark Labels - Cleanroom Classification Standards

Cleanrooms are rooms where airborne particulate matter concentration is strictly controlled. A cleanroom’s cleanliness ranking is determined by how clean the air is in accordance with the International Organization for Standardization (ISO) and the Federal Standard 290 (FED STD). ISO 14644-1 cleanrooms are classified from ISO 1 (cleanest) to ISO 9 while the Federal Standard 290 ranges from class 1 (cleanest) to class 100,000. Each cleanroom class is denoted by a maximum concentration of particles per cubic meter (cm3) or cubic foot (ft3) of air. At CleanMark, we house an ISO 5 (class 100) cleanroom and the table below compares the allowable particulate levels for each cleanroom classification.

What Our Customers Say

"CleanMark’s solution development process was exceptional from start to finish. The biopharma industry is heavily regulated and we needed a label that was exactly what our clients wanted- clean and particulate free. CleanMark delivers consistently time and time again."

— DA Houghtaling, Supply Chain Manager at Sanisure
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